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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K994385
Device Name BABY FACE
Applicant
SONORA MEDICAL SYSTEMS
1830 BOSTON AVE.
SUITE D
LONGMONT,  CO  80501
Applicant Contact COLLEEN HITTLE
Correspondent
SONORA MEDICAL SYSTEMS
1830 BOSTON AVE.
SUITE D
LONGMONT,  CO  80501
Correspondent Contact COLLEEN HITTLE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received12/28/1999
Decision Date 03/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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